Ignite Creation Date:
2024-05-05 @ 7:13 PM
Last Modification Date:
2024-10-26 @ 9:45 AM
Study NCT ID:
NCT00628251
Status:
COMPLETED
Last Update Posted:
2019-12-05
First Post:
2008-02-26
Brief Title:
Dose-finding Study Comparing Efficacy and Safety of a PARP Inhibitor Against Doxil in BRCAve Advanced Ovarian Cancer
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase II Open-Label Randomised Comparative International Multicentre Study to Assess the Safety and Efficacy of Different Doses of AZD2281 Given Orally Twice Daily Versus Intravenous Liposomal Doxorubicin Given Monthly in Patients With Advanced BRCA1- or BRCA2-Associated Ovarian Cancer Who Have Failed Previous Platinum-based Chemotherapy
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03079687
Has Expanded Access, NCT# Status:
APPROVED_FOR_MARKETING
Acronym:
ICEBERG 3
Brief Summary:
The purpose of the study is to compare the efficacy and safety of 2 doses of drug AZD2281 against liposomal doxorubicin to see which is effective and well tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and who have failed previous platinum therapy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None